EUCTR2008-002901-38-FI进行中（未招募）1 期
Randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed dose study comparing the efficacy and safety of Lu AA21004 in acute treatment of major depressive disorder in elderly patients - Not applicable
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) The patient is able to read and understand the Subject Information Sheet.
- •2) The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form.
- •3) The patient is man or woman aged 65 years or over.
- •4) The patient suffers from a recurrent Major Depressive Episode, diagnosed according to DSM-IV-TR criteria (classification code 296.3x), as primary diagnosis.
- •5) The patient had at least one previous MDE before the age of 60 years.
- •6) The patient has a reported duration of the current MDE of at least 4 weeks prior to Screening Visit.
- •8) The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score greater then/ egual to 26.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient who meets one or more of the following criteria, both at the Screening Visit and at the Baseline Visit, is not eligible for inclusion in this study:
- •1) The patient has a Mini Mental State Exam (MMSE) score <24 (Screening Visit only)
- •2) The patient has 1 or more of the following:
- •- Any current anxiety disorders as defined in the DSM-IV-TR (as assessed by the
- •Mini International Neuropsychiatric Interview [MINI]).
- •- Current or past history of manic or hypomanic episode, schizophrenia or any
- •other psychotic disorder, including major depression with psychotic features,
- •mental retardation, organic mental disorders, or mental disorders due to a
- •general medical condition as defined in the DSM-IV-TR.
- •- Any substance disorder (except nicotine and caffeine) within the previous 6
- •months as defined in the DSM-IV-TR.
- •- Presence or history of a clinically significant neurological disorder (including
- •- Neurodegenerative disorder (Alzheimer disease, Parkinson’s disease, multiple
- •sclerosis, Huntington disease, etc.).
- •- Any Axis II disorder that might compromise the study.
- •3) The patient has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
- •4) The patient has received electroconvulsive therapy within the 6 months prior to Screening
- •5) The patient is currently receiving formal cognitive or behavioural therapy, systemic psychotherapy, or plans to initiate such therapy during study.
- •6) The current depressive symptoms of the patient are considered by the investigator to have been resistant to two adequate antidepressant treatments of at least 6 weeks duration each at the recommended dose.
- •7) The patient has a history of lack of response to previous adequate treatment with duloxetine (including current episode).
- •8) The patient has increased intra-ocular pressure or is at risk of acute narrow angle glaucoma.
- •9) The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to duloxetine.
- •10) The patient used/uses disallowed recent or concomitant medication (specified in Appendix II in the protocol) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
- •11) The patient has a chronic liver disease.
- •12) The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance.
- •13) The patient had a myocardial infarction within the previous 6 months.
- •14) The patient has clinically significant abnormal vital signs as determined by the investigator.
- •15) The patient has one or more laboratory values outside the normal range, based on the blood samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
- •16) The patient has TSH value outside the normal range at Screening Visit.
- •17) The patient has a clinically significant abnormal ECG at Screening Visit.
- •18) The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
- •19) The patient, in the opinion of the investigator, is unlikely to
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